ICHQ7 Compliance challenges in modern API manufacturing MasterClass - EU edition

04-06 November, 2025

How to implement increasing challenges using ICHQ7

The courses provide an excellent knowledge of the requirements laid down in ICH Q7 and ICH Q7 Q&A.

04-06 November, 2025, Virtual

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Key learnings

Q&A

ICH Q7 and ICH Q7 Q&A - Hot topics and requirements

RBA

Use of risk-based approaches using real life examples

GMP

Lean GMP processes

Trusted by over 17,000 delegates across leading companies

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Overview

The courses provide an excellent knowledge of the requirements laid down in ICH Q7 and ICH Q7 Q&A
GMP hot topics of the guideline will be explained using real life examples.
Practical advices will be given on how to fulfil the requirements of ICH Q7.
Key principles of risk management, quality systems, development and manufacture of APIs as they are described in ICH Q7, Q9, Q10, Q11 and the ICH Q7 Q&A Document will be discussed

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Trainer

Francois Vandeweyer

Company owner
VDWcGMP Consultancy gvc

Francois (Swa) joined Janssen Pharmaceutica (part of Johnson & Johnson) in 1981. Until 1995 increasing responsibilities within the organisation mainly in the Quality Control Unit. Starting from 1995 he joined the Quality Assurance. In 2005 Senior Manager GMP Compliance Chemical Operations Belgium (sites Geel Olen Beerse). In 2009 Director Global Compliance EMEA/Asia Pacific for Johnson & Johnson.

Swa retired from J&J in May 2019. Since that time is a freelance consultant.

As a member of APIC, Swa was Vice Chair of the APIC Quality Working Group involved in multiple GMP Compliance documents like ICH Q7 How to do, Auditing Regulatory Starting Materials, supply chain integrity,.

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Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

WHO SHOULD ATTEND

This training course is designed for all persons involved in the manufacture of APIs manufactured by chemical syntheses, especially for persons from production, quality control, quality assurance, technical and regulatory affairs departments as well as for Qualified Persons and Auditors. The course also addresses interested parties from engineering companies, from the API and Pharmaceutical industry and GMP inspectorates.

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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